Professional Documents
Culture Documents
August 2015
Foreword
2014/68/EU was published on June 27, 2014 in the European Union (EU) Official Journal approved by
the European Parliament and of the Council of May 15, 2014 as a part of a larger initiative by the EU to
bring nine European Commission (EC) New Approach Directives, such as 97/23/EC, into alignment
with the New Legal Framework (NLF) which was adopted in 2008. The prime objective of the NLF
Pressure Equipment Directive 2014/68/EU is alignment, to ensure a pattern of consistency is followed
that is evident between this and all other directives. The essential safety requirements remain virtually
unchanged with the exception of the addition of risk analysis which will be discussed in the synopsis.
In an effort to avoid confusion between the two Pressure Equipment Directives, this synopsis will refer to
the outgoing New Approach PED 97/23/EC as 97/23/EC and the New Legal Framework Pressure
Equipment Directive 2014/68/EU as 2014/68/EU.
Compared to 97/23/EC, the 2014/68/EU has grown in size by almost 60% to 96 pages, it now has seven
Chapters containing 52 Articles and a further six Annexes. Although there are extensive additions, a
number of deletions and changes to the document, the impact on manufacturers is less than might be
imagined. The majority of the additions concern the Notification of Conformity Assessment Bodies and
EU legal aspects. This document will assist manufacturers in identifying the areas that need to be
addressed for future compliance. There were several editorial changes made between the two directives
that will not be covered within this document, but all significant changes applicable for the manufacturer
will be addressed.
2014/68/EU will be implemented in two parts. The first part became mandatory on June 1, 2015, and is
in relation to Article 13, Classification of pressure equipment. The second part, the replacement of the
97/23/EC becomes effective July 19, 2016. This implementation is discussed in detail below.
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HSB Global Standards
Pressure Equipment Directive
(PED 2014/68/EU) Synopsis
Importers and distributers have defined responsibilities when they have reason to believe the equipment
is not in conformity to the Directive. This includes informing the market surveillance authorities where
this presents a safety risk.
Article 10, NLF PED contains important information for importers and distributers. It states when they
place the equipment on the market under their own name or trademark that they shall be considered as
a manufacturer (and thus bear the associated responsibilities of the manufacturer, as described in the
Directive). This requirement is not intended to apply to such organizations who place the equipment on
the market under the original manufacturers name, for example valve stockists who hold catalogues of
valves where the manufacturer is clearly identified.
Article 10 also details firm rules when an importer or distributer modifies the equipment in such a way
that compliance with the Directive may be affected. If they make such modifications before placing on
the market then they are to be considered a manufacturer.
Generally the responsibilities of the manufacturer, or authorized representatives, remain the same in
2014/68/EU.
The CLP re-classifies certain substances from the Dangerous Substances Directive. The European
Commission conducted an assessment regarding the effects of the re-classifications and concluded that
only a small number of substances/mixtures would be affected and that the impact on manufacturers
would be minimal.
Article 9 of 97/23/EC outlines the provisions for dangerous fluids (substances) and classifies them in
Group 1, all other fluids not referenced were placed in Group 2. Article 13 of 2014/68/EU classifies
substances and mixtures as hazardous and places them in Group 1, all other substances and mixtures
fall into Group 2. The hazardous substances and mixtures are now broken down into 17 different
physical and health classes in accordance with Parts 2 and 3 of Annex I in the CLP Regulation.
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HSB Global Standards
Pressure Equipment Directive
(PED 2014/68/EU) Synopsis
What this means for manufacturers is that all equipment CE marked after June 1, 2015 must have its
fluid group determined by the new regulation. This applies even to existing designs already certified on a
B (EC-Type Examination), B1 (EC Design Examination) certificate and those also approved under the
module H1 design examination certificates. All pressure equipment manufacturers are encouraged to
review the fluid groups based on the equipments contents. Should the fluid group change from Group 2
to Group 1 when performing this against the CLP Regulation, then the category of the equipment should
also be re-checked. If this results in a change in the category of the equipment, then this will require
revision or possible invalidation of the certificate if it results in a higher category than the module may be
applied to. Manufacturers are encouraged to contact the Notified Body should this occur. As mentioned
before the EC has stated that these will affect only a very small number of substances, but it is
essential the check is performed.
The labels associated with the substances and mixtures have also been changed to coincide with the
CLP, manufacturers are also encouraged to review these.
Annex I, paragraph 3 was revised. In 97/23/EC this paragraph stated that the manufacturer was
responsible for performing a hazard analysis in order to identify those which apply to the equipment on
account of pressure, and then take these into account in the design of the equipment. The revision has
introduced only two words and risks. 2014/68/EU now requires the manufacturer to analyze the
hazards and risks as they apply to the equipment. Although a minimal amount of text has been added,
the impact of these two words, and how the manufacturer is to address this adequately, is still being
discussed in the Conformity Assessment Body forums.
Whilst a hazard analysis considers such common and less common factors as overpressure, fatigue,
brittle fracture, wind, earthquake, fire, explosion and so on, its implied that a risk analysis would take this
a step further, most likely considering the probability and the magnitude of a failure. Its understandable
that this presents a problem for the majority of manufacturers, such finite details regarding the location
and nature of the installation is usually unknown and often the final user will not readily release such
information.
Our Design Check List template (DCL, form QP10.3-F.002) has always addressed risk evaluation at a
fundamental level and was compiled following the results of discussions at the EU Conformity
Assessment Body Forum in Brussels at the onset of the 97/23/EC. We know from these discussions that
Registered Address: Baker Tilly Marlborough House Victoria Road South Chelmsford Essex CM1 1LN England Registration Number: 02708264
HSB Global Standards
Pressure Equipment Directive
(PED 2014/68/EU) Synopsis
there was always an underlying belief that the hazard analysis should include the consideration of risk
otherwise the use of Annex I 1.2 bullet points could not be technically justified. We continue to be
involved in CABF meetings at national and European level that include discussions regarding the
resulting expectations from the addition of and risks and hope that the outcome will be no more
onerous in the future than it is now for our manufacturers completing our DCL.
This means in the future when selecting modules for 2014/68/EU the following selection options will
apply. It continues to be acceptable to choose to apply a module for a higher category equipment to any
equipment which has a lower category.
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HSB Global Standards
Pressure Equipment Directive
(PED 2014/68/EU) Synopsis
The names of some of the modules have also changed as detailed in the table below, these new names
more accurately summarize the manufacturers and notified bodies duties, particularly with regard to the
required unexpected visits. These are now clearly indicated as supervised pressure equipment checks at
random intervals.
The terms EC Type-Examination and EC Design-Examination' have also been replaced with the term
"EU-Type Examination".
Annex III still addresses the conformity assessment procedures. Although there are changes in some of
the layout and text descriptions, the module requirements remain the same in principal. Generally the
text has been expanded in each module description for clarification, and revised in its layout and
formatting. It has also removed many of the cross references between modules that is present in
97/23/EC, 2014/68/EU now lists each modules responsibilities and requirements in full under each
module heading. There is guidance provided within each module description for CE marking and EU
Hartford Steam Boiler UK Limited
Crosby Court 28 George Street Birmingham, B3 1QG United Kingdom
Notified Body Number 2561
Registered Address: Baker Tilly Marlborough House Victoria Road South Chelmsford Essex CM1 1LN England Registration Number: 02708264
HSB Global Standards
Pressure Equipment Directive
(PED 2014/68/EU) Synopsis
declaration of conformity, where applicable to the module. There is also a section added to each module
to detail the responsibilities of an Authorised representative, when used.
Article 48
Although there no transition period as described above, there is a paragraph written into Article 48 that
will greatly assist manufacturers, and Notified Bodies, to cope with this immediate transition.
Article 48 states that certificates and decisions issued by conformity assessment bodies under Directive
97/23/EC shall be valid under this directive.
What this means is that all certificates issued under 97/23/EC, and this includes Quality System
Certificates, EC-Type and EC-Examination certificates, remain valid without need for revision following
the implementation of 2014/68/EU on July 19 2016.
For example:
A valid module B1 certificate issued referencing 97/23/EC, remains valid as an EU-Type
examination certificate for Module B (Design).
A valid Quality System Certificate for Module H1, including associated design certificates, remain
valid without revision under 2014/68/EU.
In addition to certificates, the Article also states that decisions under 97/23/EC remain valid. What
this means is for equipment that is applied under module G for example, if the design part of the
conformity assessment is completed and accepted by the Notified Body, before July 19, 2016,
then the decision to accept the design remains valid once 2014/68/EU becomes effective.
HSB GS will provide more information in due course with details about how certificates may be
revised to reference 2014/68/EU if requested by the manufacturer, or when certificates are
renewed.
Registered Address: Baker Tilly Marlborough House Victoria Road South Chelmsford Essex CM1 1LN England Registration Number: 02708264
HSB Global Standards
Pressure Equipment Directive
(PED 2014/68/EU) Synopsis
On the July 19 2016 2014/68/EU has full implementation, and 97/23/EC is withdrawn.
With 97/23/EC, there was a transition phase from the original application on November 29 1999,
until the May 29 2002, where use of the PED was optional (becoming mandatory only after May
29, 2002), there is no such luxury with the implementation of 2014/68/EU.
There is essentially no transition phase between the withdrawal of the 97/23/EC and the full
implementation of 2014/68/EU. The key stage for manufacturers to consider is the signing date of
the declaration of conformity for the equipment. This is the day that the manufacturer declares it
complies with the applicable regulation.
On the date of July 18 2016, the declaration of conformity needs to be signed with reference to
97/23/EC.
On the next day, July 19 2016, the declaration of conformity needs to be signed with reference to
2014/68/EU
Although there are no technical changes to the essential safety requirements (other than adding
risk), manufacturers need to bear these dates in mind for future pressure equipment construction,
taking into account the expected date of signing the declaration of conformity.
Guidelines
There is an ongoing effort to transfer all of the applicable old guidelines to 2014/68/EU. As there are no
real technical changes to the PED, the work is in changing the references to text and paragraphs that
appear in all the guidelines. This task has proved more time consuming then first expected, and there is
expected to be a significant delay in the completion of this guideline transfer. However, as there is no
real technical change in the guidelines, they can continue to be used once 2014/68/EU comes into
effect, provided consideration is given for the paragraph references.
2014/68/EU will also have new guidelines. At the time of this publication, two of new guidelines have just
been published along with two transposed guidelines from 97/23/EC. These new guidelines will also be
numbered differently with a prefix A-01, A-02, B-01, etc depending on their classification grouping.
Further information on this grouping will appear on 2014/68/EU website in due course:
(http://ec.europa.eu/growth/sectors/pressure-gas/index_en.htm).
Registered Address: Baker Tilly Marlborough House Victoria Road South Chelmsford Essex CM1 1LN England Registration Number: 02708264
HSB Global Standards
Pressure Equipment Directive
(PED 2014/68/EU) Synopsis
Correlation Table
Following is a correlation table, which is in Annex VI of 2014/68/EU, along with the newly introduced
Chapters, general comments giving descriptions on the contents of new or amended Articles and
Annexes.
CORRELATION TABLE
Directive
Directive 2014/68/EU Comments
97/23/EC
~~~ Chapter 1 General provisions, Articles 1 to 5
~~~ Chapter 2 Obligations of economic operators, Articles 6 to 11
~~~ Chapter 3 Conformity and classification of pressure equipment and
assemblies, Articles 12 to 19
~~~ Chapter 4 Notification of conformity assessment bodies, Articles 20 to 38
~~~ Chapter 5 Union market surveillance, control of pressure equipment and
assemblies entering the Union market, and Union safeguard
procedure, Articles 39 to 43
~~~ Chapter 6 Committee procedure and delegated acts, Articles 43 to 46
~~~ Chapter 7 Transition and final provisions, Articles 46 to 52
Article 1(1) Article 1(1) Definitions have been moved to Article 2. The Article has been
revised editorially, but there is no technical change in the scope of
the new PED.
Article 1(2) Article 2(1) to (14) Includes all the definitions from the old PED, and expands this list
significantly. New definitions are in sections (17) through (32) and
include definitions for putting into service, economic operators
etc
Article 1(3) Article 1(2) See Article 1 above
~~~ Article 2(15) to (32) See Article 2 above
Article 2 Article 3 Title changed from Market Surveillance to Making Available on the
Market and Putting Into Service. Editorially revised also.
Article 3 Article 4 Numbering and editorial revision only.
Article 4(1) Article 5(1) Added a paragraph on free movement for equipment assessed by
user inspectorate.
Article 4(2) Article 5(3) See Article 5 above.
~~~ Article 6 New Article. It correlates several major responsibilities of the
manufacturer that were previously found scattered throughout the
old PED, and lists these obligations in one article.
~~~ Article 7 New Article. Gives the responsibilities of authorized
representatives, when one is appointed by a manufacturer.
~~~ Article 8 New Article. Gives the responsibilities for importers.
~~~ Article 9 New Article. Gives the responsibilities for distributers.
~~~ Article 10 New Article. Important Article highlighting that when importers or
distributers place equipment on the market under their own name
or trademark, or modify equipment already on the market, that
they shall be considered as a manufacturer for the purpose of the
Directive.
~~~ Article 11 New Article. Economic operators responsibilities regarding
requests from Market Surveillance Authorities
Article 5 ~~~ Deleted, included in Article 12, see below
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HSB Global Standards
Pressure Equipment Directive
(PED 2014/68/EU) Synopsis
Article 6 ~~~ Deleted, now obsolete
~~~ Article 12(1) New Article. Presumption of Conformity, includes intent of Article 5
97/23/EC
Article 7(1) Article 45 Part of Chapter 6. Committee procedure and delegated acts
Delegated power, expands on empowerment of the Commission to
take actions for safety reasons
Article 7(2) Article 44(1) Part of Chapter 6. Requirements for the Committee on Pressure
Equipment according to the addressed Regulation
Article 7(3) ~~~ Deleted, now obsolete
Article 7(4) Article 44(5), second Part of Chapter 6. Change of wording, same intent, addressed
subparagraph Regulation number
Article 8 ~~~ Deleted, requirements expanded, see Chapter 5, Articles 39 to 43
below
Article 9(1) Article 13(1), introductory Identical
sentence
Article 9(2) point ~~~ Deleted, obsolete
1
~~~ Article 13(1)(a) Group 1 substances and mixtures, references CLP Regulation
Article 9(2) point Article 13(1)(b) Group 2 substances and mixtures
2
Article 9(3) Article 13(2) Identical
Article 10 Article 14 Editorial changes, deletion of paragraph 1.1, text references the
module changes
Article 11(1) Article 15(1) Identical
Article 11(2) Article 15(2) Editorial changes only
Article 11(3) Article 15(3) Editorial changes only
Article 11(4) Article 12(2) Identical
~~~ Article 15(4) New paragraph, Commission shall publish approval of EAM that
meet Annex in the OJ
Article 11(5) Article 15(5) Identical
~~~ Article 15(6) New paragraph, withdrawal of EAM from the OJ
Article 12 ~~~ Revised and included under Article 24
Article 13 ~~~ Revised and included under Article 24
Article 14(1) Article 16(1) Identical
Article 14(2) Article 5(2) Editorial changes only
Article 14(3) to Article 16(2) to (7) Editorial changes only
(8)
Article 14(9) and ~~~ Intent included in Article 32
(10)
~~~ Article 17 New Article References DOC requirements
~~~ Article 18 References the Regulation regarding the principles of CE Marking
Article 15(1) ~~~ Deleted, obsolete, information contained in Article 18
Article 15(2) Article 19(1) Editorial changes only
Article 15(3) Article 19(2) Editorial changes only
Article 15(4) and ~~~ Deleted
(5)
~~~ Article 19(3) to (6) New paragraphs regarding CE Marking, Reinforcement of
requirements previously in modules or not addressed
Registered Address: Baker Tilly Marlborough House Victoria Road South Chelmsford Essex CM1 1LN England Registration Number: 02708264
HSB Global Standards
Pressure Equipment Directive
(PED 2014/68/EU) Synopsis
Registered Address: Baker Tilly Marlborough House Victoria Road South Chelmsford Essex CM1 1LN England Registration Number: 02708264
HSB Global Standards
Pressure Equipment Directive
(PED 2014/68/EU) Synopsis
Registered Address: Baker Tilly Marlborough House Victoria Road South Chelmsford Essex CM1 1LN England Registration Number: 02708264
HSB Global Standards
Pressure Equipment Directive
(PED 2014/68/EU) Synopsis
Annex IV ~~~ Deleted. Information contained within chapter 4 now
Annex VII ~~~ Deleted. Information contained within chapter 4 now
Annex VII ~~~ Deleted
Annex VII Annex IV EC Declaration of Conformity has been renamed to EU
Declaration of Conformity. There have been small changes to the
options for content of the declaration, as well adding a format for
particulars of the signatory authorized to sign, where appropriate.
~~~ Annex V Gives the formal repeal of directive 97/23/EC
~~~ Annex VI Correlation table. Follows the format of this table and gives the
correlation between Articles and Annexes
For more information pertaining to the new Directive please see the following links:
This Synopsis was prepared by the HSB Global Standards Notified Body Staff to provide insights into the
intent of these changes, and their potential impact on PED users.
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